Impact of the Coronavirus Disease 2019 Pandemic on Physical and Mental Health of Patients With COPD: Results From a Longitudinal Cohort Study Conducted in the United States (2020-2021)

Zhang, William Z.; LaBedz, S.L.; Holbrook, Janet T.; Gangemi, A.J.; Baalachandran, Ramasubramanian; Eakin, Michelle N.; Wise, Robert A.; Sumino, Kaharu

doi:10.15326/jcopdf.2022.0287

Cited by 1 publication

(1 citation statement)

References 31 publications

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“…Despite these, the exacerbation rate defined by the E-RS and time–to–first event favored icenticaftor therapy, although this was not statistically significant. The signal for HCRU-defined exacerbations was less obvious, suggesting that icenticaftor mostly affected milder, self-managed events in the present cohort and/or that patients avoided healthcare contact during the pandemic ( 30 ).…”

Section: Discussionmentioning

confidence: 81%

Icenticaftor, a CFTR Potentiator, in COPD: A Multicenter, Parallel-Group, Double-Blind Clinical Trial

Martínez

Criner

Geßner

et al. 2023

Am J Respir Crit Care Med

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Rationale CFTR (cystic fibrosis transmembrane conductance regulator) dysfunction is associated with mucus accumulation and worsening chronic obstructive pulmonary disease (COPD) symptoms. Objectives The aim of this phase IIb dose-finding study was to compare a CFTR potentiator, icenticaftor (QBW251), with placebo in patients with COPD and chronic bronchitis. Methods Patients with COPD on triple therapy for at least three months were randomized to six treatment arms (icenticaftor 450, 300, 150, 75, or 25 mg or placebo twice daily [b.i.d.]) in a 24-week, multicenter, parallel-group, double-blind study. The primary endpoint was change from baseline in trough FEV 1 after 12 weeks. Secondary endpoints included change from baseline in trough FEV 1 and Evaluating Respiratory Symptoms in COPD (E-RS) total and cough and sputum scores after 24 weeks. Multiple comparison procedure-modeling was conducted to characterize dose–response relationship. Rescue medication use, exacerbations, and change in serum fibrinogen concentration after 24 weeks were assessed in exploratory and post hoc analyses, respectively. Measurements and Main Results Nine hundred seventy-four patients were randomized. After 12 weeks of icenticaftor treatment, no dose–response relationship for change from baseline in trough FEV 1 was observed; however, it was observed for E-RS cough and sputum score. A dose–response relationship was observed after 24 weeks for trough FEV 1 , E-RS cough and sputum and total scores, rescue medication use, and fibrinogen. A dose of 300 mg b.i.d. was consistently the most effective. Improvements for 300 mg b.i.d. versus placebo were also seen in pairwise comparisons of these endpoints. All treatments were well tolerated. Conclusions The primary endpoint was negative, as icenticaftor did not improve trough FEV 1 over 12 weeks. Although the findings must be interpreted with caution, icenticaftor improved trough FEV 1 ; reduced cough, sputum, and rescue medication use; and lowered fibrinogen concentrations at 24 weeks. Clinical trial registered with www.clinicaltrials.gov (NCT 04072887).

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Section: Discussionmentioning

confidence: 81%